Home NDC 65862-654 Entacapone
Product NDC 65862-654
11-digit product format 658620654
Labeler code 65862
Product ID 65862-654_54466878-6cce-44e7-8188-27b6091a5d15
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Entacapone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA203437
Marketing category ANDA
Marketing start 2015-06-19
Substance ENTACAPONE
Active strength 200 mg/1
Pharmacologic classes Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203437-001 ENTACAPONE ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203437-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203437-001 ENTACAPONE 200MG TABLET / ORAL AB 2015-06-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Entacapone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENTACAPONE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4975G9NM6T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 317094 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65862-654-01 Entacapone 100 in 1 BOTTLE TABLET, FILM COATED 100 8 65862-654-99 Entacapone 1000 in 1 BOTTLE TABLET, FILM COATED 1000 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ENTACAPONE ACTIVE INGREDIENT 4975G9NM6T ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 ENTACAPONE ACTIVE MOIETY 4975G9NM6T ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 HYDROGENATED COTTONSEED OIL INACTIVE INGREDIENT Z82Y2C65EA ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-654 ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 8 Current NDC, Legacy NDC, 2 package rows 20240510_d9cc1327-5474-4136-970a-ec40c41975b2.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65862-654-01 65862065401 100 TABLET, FILM COATED in 1 BOTTLE (65862-654-01) 2015-06-19 0000-00-00 No No Current 65862-654-99 65862065499 1000 TABLET, FILM COATED in 1 BOTTLE (65862-654-99) 2015-06-19 0000-00-00 No No Current